Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant
NCT ID: NCT00343785
Last Updated: 2017-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2006-02-28
2012-08-31
Brief Summary
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Detailed Description
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I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 2.0-2.5 x 10\^8 nucleated cells/kg.
SECONDARY OBJECTIVES:
I. Engraftment and overall survival.
OUTLINE:
CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2.
TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or orally (PO) twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
After completion of study treatment, patients are followed up at on day 180, 1 year, 1.5 years, 2 years, 3 years, and yearly thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (conditioning regimen, transplant, GVHD prophylaxis)
Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
cyclophosphamide
Given IV
anti-thymocyte globulin
Given IV
cyclosporine
Given IV or PO
allogeneic bone marrow transplantation
Undergo allogeneic bone marrow transplantation
methotrexate
Given IV
DNA analysis
Correlative studies
flow cytometry
Correlative studies
polymorphism analysis
Correlative studies
laboratory biomarker analysis
Correlative studies
Interventions
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cyclophosphamide
Given IV
anti-thymocyte globulin
Given IV
cyclosporine
Given IV or PO
allogeneic bone marrow transplantation
Undergo allogeneic bone marrow transplantation
methotrexate
Given IV
DNA analysis
Correlative studies
flow cytometry
Correlative studies
polymorphism analysis
Correlative studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Availability of an human leukocyte antigen (HLA)-matched family member
* DONOR: Family member who is HLA-matched
* DONOR: If more than one HLA-matched family member is available, priority will be given to a donor who is genotypically HLA-identical, of appropriate cytomegalovirus (CMV) serology, ABO compatible, and, in case of a female donor, non-parous
Exclusion Criteria
* Patients who have developed clonal cytogenetic abnormalities or myelodysplastic syndrome (preleukemia)
* Patients with Fanconi's anemia
* Aplasia secondary to radiation or cytotoxic chemotherapy
* Patients with paroxysmal nocturnal hemoglobinuria who have not developed aplastic anemia
* Severe organ toxicities:
* Cardiac insufficiency requiring treatment or symptomatic coronary artery disease;
* Severe hypoxemia , partial pressure of oxygen (pO2) \< 70 mm Hg, with decreased diffusion capacity of carbon monoxide (DLCO) \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted;
* Impaired renal function (creatinine \> 2 times upper limit of normal or estimated creatinine clearance \< 60 ml/min)
* Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
* Human immunodeficiency virus (HIV)-positive patients
* Females who are pregnant or breast-feeding
* DONOR: Donors who have increase anesthetic risk and are not able psychologically and medically to tolerate the procedure
* DONOR: HIV-positive donors
65 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Rainer Storb
Principal Investigator
Principal Investigators
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Rainer Storb
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2010-01781
Identifier Type: REGISTRY
Identifier Source: secondary_id
2054.00
Identifier Type: -
Identifier Source: org_study_id
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